Drug Controls: The FDA tries to get tough

America’s drug regulator, the Food and Drug Administration (FDA), is finally trying to toughen up its act. 

Its impotence to step in over the Vioxx (rofecoxib) debacle was one of the last straws for America’s Senate.  At the time, a member of the FDA’s drug safety team told senators that the agency was “virtually defenceless” against another “tragedy and a profound regulatory failure”.

At the heart of the problem are the differences in pre- and post-marketing trials.  A drug must go through innumerable, and well-monitored, tests before it is granted a licence.  But once the manufacturer has won the hard-earned licence, all the controls go out the window.  Information that questions the safety of the drug often gets hidden or lost, while positive results are ‘massaged’ with the help of an interesting interpretation of trial results.

To counter this, the FDA is introducing closer monitoring of a drug’s adverse events once it is being prescribed.  This includes a ‘report card’, which doctors can complete for the regulator.

This idea, while admirable, has been tried in the UK for the past 30 years, and has been known as the ‘yellow card’ system.  Sadly, it’s been reckoned that doctors reported only about 5 per cent of adverse reactions, and the scheme has almost fallen into disuse.  The situation is worse in France, where it’s been estimated that doctors report just one in 20,000 drug reactions.

As commentators suggest, voluntary schemes are fine, but the FDA really needs strong and far-reaching powers, courtesy of Congress, if it is going to protect the patient.

(Source:  British Medical Journal, 2007; 334: 290-1).


E-news broadcast 15 February 2007 No.334 [Subscribe]